Package leaflet: Information for the patient

Zyrtec, 1 mg/ml, oral solution
Cetirizini dihydrochloridum
Please read the entire leaflet carefully before using this medicine, because it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Zyrtec is and what it is used for
Important information before taking Zyrtec
How to take Zyrtec
Possible side effects
How to store Zyrtec
Contents of the pack and other information

1. What Zyrtec is and what it is used for

The active substance in Zyrtec is cetirizine dihydrochloride.
Zyrtec is an antiallergic medicine.
Zyrtec 1 mg/ml oral solution is indicated in adults and children aged 2 years and older:

for relief of nasal and ocular symptoms associated with seasonal and perennial allergic rhinitis,
for relief of symptoms of urticaria.

2. Important information before using Zyrtec

When not to use Zyrtec

if the patient has end-stage renal failure (severe kidney failure requiring dialysis),
if the patient is allergic to cetylpyridinium chloride dihydrochloride or any of the other ingredients of this medicine (listed in section 6), hydroxyzine, or piperazine derivatives (substances with similar structure included in other medicines).

Warnings and precautions
Before starting treatment with Zyrtec, discuss it with your doctor or pharmacist.
If the patient has kidney impairment, consult a doctor before using this medicine;
a lower dose may be necessary. The doctor will determine the appropriate dose.
If the patient has problems with urination (e.g. due to spinal cord or prostate issues,
or bladder problems), consult a doctor.
If the patient has epilepsy or a risk of seizures, consult a doctor.
No clinically significant interactions have been observed between alcohol (at a blood concentration of 0.5 per mille (g/l), corresponding to the level after drinking one glass of wine) and ceterizine taken at recommended doses. However, there is no safety data available regarding concomitant use of higher doses of ceterizine and alcohol. Therefore, as with other antihistamine medicines, it is recommended to avoid taking Zyrtec together with alcohol.
If the patient has planned allergy testing, ask the doctor whether the patient should stop taking Zyrtec several days before the test. Zyrtec may affect the results of allergy tests.
Zyrtec and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Taking Zyrtec with food and drink
Food does not affect the absorption of Zyrtec.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Zyrtec should be avoided in pregnant women. Accidental intake of the medicine by a pregnant woman is not expected to have harmful effects on the fetus. However, the medicine may be used only if necessary and after consultation with a doctor.
Cetirizine passes into breast milk. Adverse effects in breastfed infants cannot be excluded. Therefore, Zyrtec should not be used during breastfeeding unless otherwise decided by a doctor.
Driving and operating machinery
Clinical studies have not shown any impairment of reaction ability, concentration, or driving skills after taking Zyrtec at the recommended dose.
If the patient plans to drive, perform potentially dangerous activities, or operate machinery after taking Zyrtec, the patient should carefully monitor their body's response to the medicine. Do not exceed the recommended dose.
Zyrtec oral solution contains sorbitol (E 420), methyl parahydroxybenzoate (E 218),
propyl parahydroxybenzoate (E 216), propylene glycol (E 1520), and sodium.
This medicine contains 1,575 mg of sorbitol (E 420) in each 5 ml, which corresponds to 315 mg/ml. Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot break down fructose—has been diagnosed, the patient should contact a doctor before taking the medicine or giving it to the child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
This medicine contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (including delayed-type reactions).
This medicine contains 250 mg of propylene glycol (E 1520) in each 5 ml, which corresponds to 50 mg/ml.
The medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".

3. How to use Zyrtec

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The solution may be taken orally without dilution.
Adults and adolescents over 12 years of age:
The recommended dose is 10 mg once daily, corresponding to 10 ml of oral solution (2 full measuring
spoons).
Use in children aged 6 to 12 years:
The recommended dose is 5 mg twice daily, corresponding to 5 ml of solution (one full measuring
spoon) twice daily.
Use in children aged 2 to 6 years:
The recommended dose is 2.5 mg twice daily, corresponding to 2.5 ml of oral solution (half a measuring
spoon) twice daily.
Patients with renal function impairment
In patients with moderate renal impairment, a dose of 5 mg once daily is recommended.
If a patient has severe kidney disease, consult a doctor, who will adjust the dose accordingly.
If a child has kidney disease, consult a doctor, who will adjust the dose according to the child's needs.
If you feel that the effect of Zyrtec is too strong or too weak, consult a doctor.
Duration of treatment
The duration of treatment depends on the type, duration, and course of symptoms and is determined by
the doctor.
Taking more Zyrtec than recommended
If more Zyrtec than recommended is taken, consult a doctor. The doctor will decide whether and what
actions should be taken.
After an overdose, the adverse reactions listed below may occur with increased intensity. The following adverse reactions have been reported: disorientation, diarrhoea, dizziness, fatigue, headache, malaise, pupil dilation, itching, motor restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention (difficulty completely emptying the bladder).
Missed dose of Zyrtec
Do not take a double dose to make up for a missed dose.
Stopping Zyrtec
In rare cases, itching (intense pruritus) and/or urticaria may recur after discontinuation of Zyrtec.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions occur rarely or very rarely; however, you should stop taking the medicine and immediately contact your doctor if any of the following occur:

allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the face and throat). These reactions may occur immediately after the first dose or may occur later.

Frequently occurring adverse reactions (may occur in up to 1 in 10 patients)

drowsiness
dizziness, headache
pharyngitis (sore throat), rhinitis (nasal discharge, nasal congestion) (in children)
diarrhoea, nausea, dry mouth
fatigue

Uncommonly occurring adverse reactions (may occur in up to 1 in 100 patients)

excitation
paraesthesia (abnormal sensations)
abdominal pain
itching, rash
asthenia (extreme tiredness), malaise

Rarely occurring adverse reactions (may occur in up to 1 in 1,000 patients)

allergic reactions, sometimes severe (very rare)
depression, hallucinations, aggressive behaviour, disorientation, insomnia
seizures
tachycardia (rapid heartbeat)
abnormal liver function
urticaria
oedema
weight gain

Very rarely occurring adverse reactions (may occur in up to 1 in 10,000 patients)

thrombocytopenia (low platelet count)
tics (habit spasms)
fainting, dyskinesia (involuntary movements), dystonia (abnormal, prolonged muscle contractions), tremor, taste disturbances
blurred vision, accommodation disorders (visual focusing problems), nystagmus (uncontrolled, circular eye movements)
angioedema (severe allergic reaction causing swelling of the face or throat), drug eruption (skin allergic reaction to a medicine)
urinary disorders (bedwetting, pain and/or difficulty in passing urine)

Adverse reactions with unknown frequency (frequency cannot be determined from available data)

increased appetite
suicidal behaviour (recurrent suicidal thoughts or interest in suicide), nightmares
amnesia (memory loss), memory impairment
dizziness (sensation of spinning or loss of balance)
urinary retention (inability to completely empty the bladder)
itching (intense pruritus) and/or urticaria after discontinuation of the medicine
joint pain, muscle pain
acute generalized exanthematous pustulosis (rash with pustules containing pus)
hepatitis

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder. By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Zyrtec

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the stated month.
Do not use after 3 months from the first opening of the bottle.
No special storage conditions required.

6. Contents of the pack and other information

What Zyrtec contains

The active substance is cetirizine dihydrochloride. 10 ml of solution (equivalent to 2 full measuring spoons) contains 10 mg of cetirizine dihydrochloride.
Other ingredients are: sorbitol (E 420), glycerol (E 422), propylene glycol (E 1520), sodium saccharin, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), banana flavour 54.330/A, sodium acetate, glacial acetic acid, purified water.
10 ml of Zyrtec oral solution (= 2 full measuring spoons) contains sorbitol equivalent to: 3.15 g of glucose.

What Zyrtec looks like and contents of the pack
Zyrtec is a clear, colourless liquid with a slightly sweet taste and banana aroma.
The pack contains a bottle with 75 ml or 200 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
VEDIM Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warszawa
Tel.: + 48 22 696 99 20

Manufacturers:
Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044 Pianezza (TO), Italy
UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom
Importer:
PHOENIX Pharma Polska Sp. z o.o., ul. Rajdowa 9, Konotopa, 05-850 Ożarów Mazowiecki
United Drug Distributors Ireland Limited, United Drug House, Magna Drive, Magna Business Park, Citywest, Road, Dublin 24, Ireland
UCB Pharma B.V., Hoge Mosten 2 A1, 4822 NH, Breda, Netherlands
UCB Pharma AS, Haakon VIIs gate 6, NO-0161 Oslo, Norway
UCB Nordic A/S, Edvard Thomsens Vej 14, DK-2300 København S, Denmark
UCB Pharma SA, Chemin Du Foriest 1, Braine-L’alleud, 1420, Belgium

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria Zyrtec 1 mg/ml - orale Lösung
Belgium Zyrtec
Cyprus Zyrtec
Denmark Zyrtec
Estonia Zyrtec
Finland Zyrtec
France Zyrtec
Ireland Zirtek oral solution 1 mg/ml
Italy Zirtec 1 mg/ml soluzione orale
Latvia Zyrtec
Lithuania Zyrtec
Luxembourg Zyrtec
Malta Zyrtec
Netherlands Zyrtec
Norway Zyrtec
Poland Zyrtec
Portugal Zyrtec
Slovenia Zyrtec 1 mg/ml peroralna raztopina
Spain Zyrtec 1 mg/ml solución oral
United Kingdom (Northern Ireland) Zirtek allergy solution